AZITHROMYCIN SANDOZ 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Azithromycin Sandoz 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Azithromycin Sandoz is and what it is used for
2. What you need to know before you take Azithromycin Sandoz
3. How to take Azithromycin Sandoz
4. Possible side effects
5. Storage of Azithromycin Sandoz
6. Contents of the pack and other information

1. What Azithromycin Sandoz is and what it is used for

Azithromycin belongs to a group of antibiotics called macrolide antibiotics. It eliminates bacteria that cause infections.

Azithromycin Sandoz is used to treat infections caused by bacteria in different parts of the body, in adults and children weighing over 45 kg.

This medication is used to treat the following bacterial infections: throat, tonsil, ear, or sinus infections,

• bronchitis and pneumonia (mild to moderate),
• skin and soft tissue infections (mild to moderate),
• urethra (urethritis) or cervix (cervicitis) infections, see section 3,

sexually transmitted infections (chancroid), see section 3.

2. What you need to know before you take Azithromycin Sandoz

Do not take Azithromycin Sandoz:

• if you are allergic to azithromycin, erythromycin, any other macrolide or ketolide antibiotic, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Azithromycin Sandoz.

• During treatment with azithromycin, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing or an allergic reaction to the medication characterized by an increase in white blood cells in the blood and generalized symptoms) may occur, which could be severe. Inform your doctor, who may decide to interrupt treatment and initiate appropriate treatment.
• If you have liver problems or during treatment, your skin and/or the whites of your eyes turn yellow, discuss this with your doctor to confirm whether you should interrupt treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor, as concomitant treatment with azithromycin may cause a potentially serious adverse reaction called ergotism.
• During treatment with this medication, there is a possibility of developing a superinfection with resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with azithromycin, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If this is the case, treatment should be suspended, and your doctor will provide the most appropriate treatment.
• If you have severe kidney function impairment, inform your doctor.
• If you have heart rhythm disturbances or factors that predispose you to them (certain heart diseases, electrolyte level alterations in the blood, or certain medications), inform your doctor, as this medication may contribute to worsening or triggering these disturbances.
• If you have a disease called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as azithromycin may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

Tablets are not indicated for this patient group. Other pharmaceutical forms containing azithromycin can be used. It should not be administered to children under 6 months.

Children and adolescents weighing over 45 kg.

This medication is not suitable for children who are unable to swallow the tablets whole. Other pharmaceutical forms containing azithromycin can be used.

Other medicines and Azithromycin Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Especially, you must inform your doctor or pharmacist if you are being treated with any of the following medicines:

• antacids (medicines used for digestive problems). It is recommended to avoid simultaneous administration of both medicines at the same time of day,
• ergotamine derivatives (such as ergotamine, for migraine treatment), as concomitant administration with azithromycin may cause ergotism (a potentially serious adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, seizures, or abdominal or chest pain),
• digoxin (a medicine used for heart rhythm disorders) as azithromycin may increase digoxin levels in the blood, and its levels should be monitored,
• colchicine (used for gout and familial Mediterranean fever),
• cyclosporin (a medicine used in transplanted patients) as azithromycin may increase cyclosporin levels in the blood, and its levels should be monitored,
• dicoumarol anticoagulants (medicines used to prevent blood clots) as azithromycin may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time),
• nelfinavir, zidovudine (medicines for the treatment of human immunodeficiency virus infections), as azithromycin levels in the blood may increase,
• fluconazole (medicines for the treatment of fungal infections), as azithromycin levels in the blood may increase,
• terfenadine (a medicine used for allergy treatment) as the combination of both may cause heart problems,
• rifabutin (a medicine for the treatment of pulmonary and non-pulmonary tuberculosis and mycobacterial infections) as it may cause a decrease in the number of white blood cells in the blood,
• medicines with active substances that prolong the QT interval, such as antiarrhythmic agents of class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacin and hydroxychloroquine or chloroquine), as it may cause serious heart rhythm disturbances and even cardiac arrest.

No interactions have been observed between azithromycin and cetirizine (for the treatment of allergic reactions); didanosine, efavirenz, indinavir (for the treatment of HIV infection); atorvastatin (for the treatment of high cholesterol and heart problems); carbamazepine (for the treatment of epilepsy), cimetidine (for the treatment of excess stomach acid); methylprednisolone (to suppress the immune system); theophylline (for respiratory problems); midazolam, triazolam (for sedation); sildenafil (for the treatment of impotence), and trimethoprim/sulfamethoxazole (for the treatment of infections).

Using Azithromycin Sandoz with food and drinks

Tablets should be taken whole with water and can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough information on the safety of azithromycin during pregnancy. Therefore, the use of azithromycin is not recommended during pregnancy, or if you are planning to become pregnant, unless it is strictly necessary according to medical judgment.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, the use of azithromycin is not recommended during breastfeeding, although you may continue breastfeeding two days after completing treatment with azithromycin.

Driving and using machines

The influence of this medicine on the ability to drive or use machines is negligible or non-existent.

Azithromycin Sandoz contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Azithromycin Sandoz

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will determine the most suitable dose and treatment duration for you, according to your condition and response to treatment. As a general rule, the recommended dose of the medicine and the frequency of administration are as follows:

Adults (including elderly patients) and children weighing over 45 kg:

The usual dose is 1500 mg divided over 3 or 5 days as follows:

• When taken over 3 days, 500 mg per day.
• When taken over 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day.

In elderly patients, the same dose as for adults can be administered. However, if they have heart rhythm disturbances, your doctor will closely monitor you.

Urethra or cervix infection (cervicitis):

The usual dose is 1000 mg taken as a single dose, in one day.

If the infection is caused by N. gonorrhoeae, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone (250 mg)).

Chancroid:

The usual dose is 1000 mg taken as a single dose, in one day.

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years.

Children and adolescents weighing less than 45 kg:

Tablets are not recommended for these patients. Other pharmaceutical forms of azithromycin can be used.

Liver impairment

Inform your doctor if you have severe liver problems, as it may be necessary to adjust the normal dose.

Kidney impairment

Inform your doctor if you have severe kidney problems, as it may be necessary to adjust the normal dose.

Method of administration

Oral use.

This medicine should be administered as a single daily dose. Tablets should be taken whole with water and can be taken with or without food.

If you take more Azithromycin Sandoz than you should

In case of overdose, you may experience reversible hearing loss, severe nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

Information for the prescriber

In case of overdose, activated charcoal administration is indicated, and symptomatic and general supportive measures for vital functions should be applied.

If you forget to take Azithromycin Sandoz

If you miss a dose, use the medicine as soon as possible, continuing with the treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one.

Do not take a double dose to make up for missed doses. Continue taking azithromycin as your doctor has indicated.

If you stop taking Azithromycin Sandoz

If you stop treatment with azithromycin before your doctor recommends, your symptoms may worsen or reappear.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects reported during clinical trials and after marketing, classified by frequency, are:

Very common side effects (may affect more than 1 in 10 people):

• diarrhea.

Common side effects (may affect up to 1 in 10 people):

• headache,
• vomiting, abdominal pain, nausea,
• alteration of the number of some types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils),
• decrease in bicarbonate in the blood.

Uncommon side effects (may affect up to 1 in 100 people):

• Candida infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration of breathing, rhinitis,
• decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils),
• allergic reaction, including a deep skin inflammation (angioedema),
• alteration of eating behavior (anorexia),
• nervousness, insomnia,
• sleepiness, dizziness, alteration of taste, loss of tactile sensation,
• vision alteration,
• hearing alteration, vertigo,
• palpitations,
• hot flashes,
• breathing alteration, nosebleeds,
• constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, eructation, mouth ulcers, increased salivation,
• rash, itching, appearance of red elevated patches, dermatitis, dry skin, excessive sweating, redness,
• joint inflammation, muscle pain, back pain, neck pain,
• difficulty urinating, kidney pain,
• vaginal bleeding, alteration in the testicles,
• generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities,
• alteration of liver function tests (increase in liver enzymes GOT, GPT, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in the blood, alteration of sodium and potassium levels, decrease in hematocrit,
• complications after surgical intervention.

Rare side effects (may affect up to 1 in 1,000 people):

• agitation,
• liver function alteration, yellowing of the skin,
• sensitivity to sun exposure (photosensitivity), drug reaction with an increase in a type of white blood cells (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome),
• skin rash characterized by the rapid appearance of red skin areas with small pus-filled bumps (small blisters filled with white/yellow liquid).

Side effects of unknown frequency (cannot be estimated from the available data):

• diarrhea produced by Clostridium difficile,
• decrease in the number of platelets in the blood, anemia,
• severe allergic reaction,
• aggressive reactions, anxiety, delirium, hallucinations,
• loss of consciousness, seizures, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis),
• hearing alteration, including deafness and ringing,
• Torsade de Pointes, heart rhythm disturbances, QTc interval prolongation in the electrocardiogram,
• decrease in blood pressure,
• pancreatitis, change in tongue color,
• severe liver damage and liver failure that can rarely be fatal, liver tissue death, fulminant hepatitis,
• appearance of red elevated patches, generalized rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), severe skin reactions such as erythema multiforme, toxic epidermal necrolysis.
• joint pain,
• acute kidney failure and inflammation of the tissue between the kidney tubules (interstitial nephritis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azitromicina Sandoz

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton, after CAD/EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Azitromicina Sandoz

• The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (as dihydrate).
• The other ingredients (excipients) are:

Core: pregelatinized maize starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate.

Coating: hypromellose (E-464), titanium dioxide (E171), lactose monohydrate, and triacetin (E-1518).

Appearance of the Product and Package Contents

The tablets are packaged in PVC/Aluminum blisters.

Azitromicina Sandoz 500 mg film-coated tablets are white, capsule-shaped tablets with a single transverse line on one side.

They are available in packs of 3 and 150 tablets (clinical packaging).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Kern Pharma, S.L.

Polígono Ind. Colón II Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of the Last Revision of this Leaflet:May 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es